I beg to differ a bit regarding the arduousness of the 510(k) preparation, as it relates to BIEL, in this case. Any government agency, as subject, will provide the preparer the Formula, boilerplate, or otherwise, a framework in regards to how a given government document is to be prepared. The 510(k) preparation process, as I can imagine, is similar to that which is associated with a “Request For Proposal” (RFP) document, of which I am familiar. But, of course, there is bound to be some tailoring of any given document of that sort, in order to humor the uniqueness associated with any given project, at hand. But it must be understood, by all accounts, that BIEL is not a virgin, in regards to this process. They have been around the block a few times, vis-à-vis, with the FDA document preparation process. They know exactly what the FDA expects, in the manner of document configuration and content. So, IMO, regarding the recent 510(k) submissions, that process should have been largely an exercise in cut-&-paste. The data is already there, but as I understand it, the trial metrics associated with men would be strip away, and the remaining trial data would be correlate to be women centric. Of course, it’s a given, that BIEL's folks are intimately familiar with that data, thus, in its relevancy and its idiosyncrasies. So, IMHO, there should not have been great difficulty in preparing those 510(k) documents. I reiterate, IMO!! So, for what it’s worth, there you have it!
GLTA!!!
News 
Market Data 
Discover 
AI
